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This report reviews, analyzes and sizes the combined molecular diagnostics product and clinical lab services markets. The study uncovers interesting information about key equipment, IVD consumables, reagents, software and services that are marketed to clinical diagnostic labs located at independent companies, hospitals, HMOs, doctors cooperatives and healthcare centers of all kinds in the developed and developing worldwide regions.
This report assesses the market and maps the competitors in this market landscape with more than 85 companies identified. The financial section sizes the market and discusses the five-year revenue projection to 2011. This study segments the market by major product and service areas, by technology, by disease/ application, and by test sample material. The report also segments the market by major world regions to see the growth opportunity.
This study reviews and analyzes major company alliances, M&As during the last two years. Large data tables summarize the alliances and M&As. The alliance table presents a large amount of partnering information.
This report reviews the molecular diagnostic technology and business trends over the next three to five years. Large and small analytical tables help the reader quicky understand the trend information.
The study methodolgy uses primary information that was gathered from numerous sources including in-person interviews and discussions, telephone interviews, and surveys, attendance at business presentations at healthcare technical and financial conferences as well a through secondary research.
This research report is designed for people that include marketers, business development, top executives, investors, VCs, consultants, R&D managers, entrepreneurs and the like. More than 51 detailed tables or figures provide key data about items such as strategic alliances, M&As, market size, segments and the like.
This report includes 30 company profiles that provide the reader a snapshot of the companies’ focus or activities. The provided Internet links help readers access companies’ own web sites for further review.

1. Overview of Molecular Diagnostic Tests
1.1 Gene-Based and ‘Omics’-Based Biomarkers Enable Molecular Diagnostics
1.1.1 Molecular Diagnostics (J added)
1.2 Diagnostic Industry Competitive Overview
1.2.1 WW Molecular Diagnostics IVD Business
1.2.2 WW Molecular Diagnostics Lab Services
1.2.3 Leading Molecular Diagnostics IVD Makers
1.2.4 Leading Molecular Diagnostics IVD Lab Services
1.3 Advances in Molecular Diagnostics
1.3.1 FDA View of Biomarkers for Molecular Diagnostic Field
1.3.2 Genetic Tests for Multiple Gene Based Diseases
1.3.3 Multiplexed Protein Patterns Become Molecular Diagnostics
1.3.4 DNA Methylation Tests
1.4 Developing Molecular Diagnostics
1.4.2 Esoteric ‘Home Brew’ Molecular Diagnostics Marketed as Services
1.4.3 Developing a Test into an In Vitro Diagnostic
1.4.4 Product Prices and the $3,200 Test!
1.4.5 Healthcare Reimbursement Issues

2. Company Activities and Strategies
2.1 Major Market Participants by Disease Segments
2.2 Important Findings or Special Notes
2.2.1 Findings of Companies in Molecular Diagnostics by Sample Material
2.2.2 Findings of Companies in Molecular Diagnostics by Major Disease
2.2.3 Findings of Companies in Molecular Diagnostics by Product ‘Status’

3. Technologies Used in Developing Molecular Diagnostics
3.1 Technologies: Current Status & Next Stage Development Status
3.2 Overview of Technologies Used in Molecular Diagnostics
3.3 Technologies and Molecular Diagnostics Products: Current and Next Stage Development
3.4 Commercial Implications of Clinical Molecular Diagnostics

4. Alliances and R&D Activity in Molecular Diagnostics
4.1 Overview of Strategic Alliances & R&D in Molecular Diagnostics
4.1.1 Alliance Types
4.1.2 Molecular Diagnostic Alliances for R&D at a Glance
4.1.3 Alliances in Molecular Diagnostics Gained Momentum in 2006
4.2 Summary of Molecular Diagnostics in Medical Research
4.3 R&D Activity by Diseases or Applications
4.3.1 Summary of R&D Activity
4.3.2 Details of R&D Activity

5. Market Size and Forecast for Molecular Diagnostics
5.1 Market Overview: Molecular Diagnostic (MDx) Products & Clinical Lab Servic
5.2 WW Molecular Diagnostic (MDx) Product/ Market Trends
5.2.1 Examples of Selected MDx Equipment and Consumable Products
5.2.2 Examples of Selected MDx Lab Services
5.3 Molecular Diagnostic (MDx) Total WW Market Size
5.3.1 Total WW MDx Market Size, 2006-2011
5.3.2 Market Size by Major Segments
5.4 Leading Molecular Diagnostic Manufacturers’ Shares
5.5 WW Molecular Diagnostic Product Market Size by Disease Segments
5.6 WW Molecular Diagnostic Product Market Size by Test Material Segments
5.7 WW Molecular Diagnostic Product Market Size by Technologies
5.8 WW Molecular Diagnostic Product Market Size by Region
5.9 WW Molecular Diagnostic Lab Services Market Size by Disease and Regions
5.9.1 MDx Lab Services Market Size by Disease
5.9.2 WW Molecular Diagnostic Lab Services Market Size by Regions

6. Future Directions
6.1 Key Trends for Molecular Diagnostics
6.1.1 Infectious Disease Testing
6.1.2 Interest in Cancer Tests Growing
6.1.3 Future Direction for CNS Disease Tests
6.1.4 Future Direction of Genetic Testing and PGx Tests
6.2 Top Opportunities for the Future
6.2.1 Government Regulators Driving Future Opportunities
6.2.2 Emerging Personalized Medicine and Timeline
6.3 Main Challenges
6.3.1 High Costs of Molecular Diagnostics
6.3.2 Acute Shortages of Diagnostics in the Developing World
6.3.3 Worldwide Regulatory Delays in Approving New Tests
6.3.4 Insurance Reimbursement Issues

7. Activities of Molecular Diagnostics Companies
7.1 Large Diagnostic Lab Services
7.1.1 BML, Inc.
7.1.2 Diagnosticos Da America S.A. (DASA)
7.1.3 LabCorp
7.1.4 Quest Diagnostics, Inc.
7.1.5 Unilabs Group
7.2 Small Diagnostic Lab Services
7.2.1 diaDexus, Inc.
7.2.2 Myriad Genetics, Inc.
7.2.3 Veridex, LLC (J&J Co.)
7.2.4 Genomic Health, Inc.
7.2.5 Agendia B.V.
7.3 Large MDx Company
7.3.1 Abbott Molecular
7.3.2 BD Diagnostics
7.3.3 Digene Corporation
7.3.4 Beckman Coulter, Inc.
7.3.5 bioMérieux SA
7.3.6 Gen-Probe, Inc.
7.3.7 Roche Molecular Diagnostics
7.3.8 Siemens Medical Solutions Diagnostics
7.4 Point of Care MDx
7.4.1 BioSite, Inc.
7.4.2 Cepheid
7.5 Pure Play MDx
7.5.1 Celera Group
7.5.2 Chiron Corporation (Novartis)
7.5.3 Dako A/S
7.5.4 Exact Sciences Corporation
7.5.5 Innogenetics NV
7.6 DNA Methylation MDx
7.6.1 Orion Genomics LLC
7.6.2 Epigenomics AG
7.7 Array Platforms
7.7.1 Affymetrix, Inc.
7.7.2 Luminex Corporation
7.7.3 Nanogen, Inc.

8. Appendix
8.1 Major Disease Population Sizes
8.2 Companies Mentioned in This Report


LIST OF TABLES

Table 1. Molecular IVD Test Applications
Table 2. Top Molecular Diagnostics IVD Players
Table 3. Top Independent MDx IVD Lab Services Players
Table 4. Typical Molecular Diagnostic IVD Development Path
Table 5. Market Participants by Disease, Company, MDx Products (n=356)
Table 6. Company Activities by Sample Material Totals and Shares
Table 7. Company Activities by Major Disease Totals and Shares
Table 8. Company Activities by ‘Product Status’ Segment Totals and Shares
Table 9. Technologies: Current Status & Next Stage Development by Count
Table 10. Technologies Market Share: 2006 vs. 2009 vs. 2011 by Product Pipelines
Table 11. Technologies, Major Companies and Relationship
Table 12. Technologies and MDx Products: Current and Next Stage Development
Table 13. Vendor Competition by Nucleic Acid Amplification Technologies for Clinical
Molecular Diagnostics and by Estimated Shares and Revenues
Table 14. Strategic Alliances Summary by Alliance Type, 2004 to 2007
Table 15. Summary of M&As by Year, Buyer, Alliance Type, Size, 2004 to 2007
Table 16. Alliances Summary by Major Diseases, Jan-2004 to Mar-2007
Table 17. Alliances for Molecular Diagnostics by Major Disease, 2007
Table 18. Alliances for Molecular Diagnostics by Major Disease, 2006
Table 19. Alliances for Molecular Diagnostics by Major Disease, 2005
Table 20. Alliances for Molecular Diagnostics by Major Disease, 2004
Table 21. Examples of Selected MDx Equipment and Consumable Products
Table 22. Examples of Selected MDx Lab Services and Prices
Table 23. Total WW MDx Market Size, 2006-2011
Table 24. WW MDx Market Size and Forecast by Major Segments
Table 25. Molecular Diagnostic Manufacturer Revenues ($M) & Shares (%)
Table 26. MDx Products by Major Diseases/ Applications & Revenues
Table 27. MDx Products by Test Material & Revenues
Table 28. MDx Products by Technology & Revenues
Table 29. MDx Product Market Size by WW Regions
Table 30. Molecular Diagnostic Lab Services by Disease Segments
Table 31. MDx Clinical Lab Services by WW Regions and Revenues
Table 32. Future Direction of Infectious Disease Tests
Table 33. Future Direction of Cancer Companion Tests and Targeted Medicine
Table 34. Future Direction of Cancer Tests
Table 35. CNS Tests Likely in Five Years
Table 36. Future Direction of Pharmacogenomics (PGx) Tests
Table 37. Future Genetic Tests for Risk Prediction
Table 38. Selected Companion Diagnostics (PGx) and Targeted Therapies
Table 39. Estimated Patient Populations by Disease in the Developed World
Table 40. Top Health Risk Factors Leading to Death in the Developed World
Table 41. Companies Mentioned in This Report


LIST OF ILLUSTRATIONS

Figure 1. WW Molecular Diagnostics Business
Figure 2. The Fastest Growing IVD and Lab Services Businesses
Figure 3. Total WW MDx Market Size, 2006-2011
Figure 4. WW MDx Market Size by Major Segments
Figure 5. MDx Products by Major Diseases/ Applications & Revenues
Figure 6. MDx Products by Test Material & Revenues
Figure 7. MDx Products by Technology & Revenues
Figure 8. MDx Product Market Size by WW Regions
Figure 9. Molecular Diagnostic Lab Services by Disease Segments
Figure 10. MDx Clinical Lab Services by WW Regions and Revenues